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Central Mechanisms That Regulate Glucose Metabolism in Humans

This study is currently recruiting participants.
Verified June 2017 by Meredith Hawkins, Albert Einstein College of Medicine, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028846
First Posted: December 9, 2009
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine, Inc.
December 7, 2009
December 9, 2009
June 29, 2017
May 2011
September 2020   (Final data collection date for primary outcome measure)
Endogenous Glucose Production [ Time Frame: 4 hours ]
Not Provided
Complete list of historical versions of study NCT01028846 on ClinicalTrials.gov Archive Site
Glucose Uptake [ Time Frame: 4 hours ]
Not Provided
Not Provided
Not Provided
 
Central Mechanisms That Regulate Glucose Metabolism in Humans
Central Mechanisms That Regulate Glucose Metabolism in Humans
The purpose of this study is to understand how diazoxide, a medication that has been shown to have effects on insulin and other hormone secretion, can regulate the production of sugar by the liver.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Diazoxide
    4mg-6mg/kg orally once before study
  • Drug: Glyburide
    Administered orally at beginning of study
  • Device: Vagal Nerve Stimulator
    Device approved for the purpose of decreasing seizure frequency in patients with poorly-controlled epilepsy
  • Active Comparator: Diazoxide
    Intervention: Drug: Diazoxide
  • Active Comparator: Glyburide
    Intervention: Drug: Glyburide
  • Active Comparator: Vagal Nerve Stimulator
    Intervention: Device: Vagal Nerve Stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2020
September 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • BP < 130/90 (+-2 meds)
  • BMI < 35
  • Normal screening labs (CBC, chemistry, lft's PT/PTT)
  • No CAD
  • No first degree relatives with history of CAD or MI (men < 45; women < 55)
  • Good IV access
  • Noth other medical problems with exception: HTN (on < or = 2 meds), hypercholesterolemia, and stable retinopathy
  • Non-smoker
  • Hemoglobin A1C 7.5-11

Exclusion Criteria:

  • BP>130/90 (+- medications)
  • BMI > 35
  • Abnormal EKG
  • History of CAD or exertional chest pain
  • First degree relative with early CAD or MI
  • Medications for medical or psychiatric conditions including: dofetilide, fosphenytoin/phenytoin trichlormethiazide (any thiazide), chlorpromazine and warfarin
  • < 4 week history of participation in another drug trial
Sexes Eligible for Study: All
21 Years to 60 Years   (Adult)
No
Contact: Morgan Drucker, BS Morgan.drucker@einstein.yu.edu
United States
 
 
NCT01028846
2006-414
Yes
Not Provided
Not Provided
Meredith Hawkins, Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
Not Provided
Principal Investigator: Meredith Hawkins, MD Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP